New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:

11/10/2010

Trade Name:

Vyvanse Capsules

Generic Name or Proper Name (*):

lisdexamfetamine

Indications Studied:

ADHD

Label Changes Summary:

* Expanded indication to include adolescent patients ages13-17 years; previously approved for use in 6-12 years * Most common adverse reactions were decreased appetite, insomnia, and decreased weight* Information on clinical trial, adverse reactions